510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K770831Substantially Equivalent

Statzyme Uric Acid Reagent

Worthington Biochemical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770831 is the FDA 510(k) clearance record for STATZYME URIC ACID REAGENT, a class I device, cleared for Worthington Biochemical Corp. on under FDA product code CDO (Acid, Uric, Uricase (U.V.)). FDA records list 13 510(k) clearances for Worthington Biochemical Corp., from to . As of , FDA records show no recalls naming K770831.

Clearance record

Decision date
Received
(66 days to decision)
Product code
CDO Acid, Uric, Uricase (U.V.)
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Worthington Biochemical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CDO

Trailing 12 months

FDA records hold no clearances under product code CDO in the trailing twelve months.

FDA records show no clearances under product code CDO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260